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腾讯登录赛默飞HPLC获得FDA一类医疗器械
| 导读 | Thermo Fisher Scientific今天宣布，该公司产品Prelude LX-4 MD HPLC已经列入美国食品和药物管理局（FDA）的一类医疗器械名单中，而该名单中的产品，一般可以在临床使用。 |
该公司还表示，其与Prosolia公司签署了协议，该协议主要关于该公司的样品自动化处理和质谱的电离源。
Prelude LX-4 MD HPLC具有四个并行的通道，能够提供多达四种，不同的分离方式，这样可以提高到质谱的样品量。赛默飞表示，这些通道可以以相同的或者不同的方式运行。
居于一类的医疗器械，对于患者具有最小的风险，同时，FDA对三类医疗器械的监管中，对于一类是最少的。
在一份申明中，Thermo Fisher Chromatography and Mass Spectrometry总裁Dan Shine表示，该公司致力于LC-MS的临床市场，“这个产品仅仅是我们一个大计划的启动，我们计划让更多的临床医生接触和使用质谱。”
去年六月，Thermo Fisher在加利福尼亚圣何塞市注册。伴随着FDA批准的医疗器械的工厂的建立，该公司能够制造用于体外诊断的设备，这些设备能够分析患者的样本。
另外，今天该公司还表示，其与经销商Prosolia达成了协议，允许其销售Prosolia Velox 360和Thermo Fisher的质谱仪器。该协议包括了一个单一联系的采购，安装和相关服务。
Velox 360是一个可以自动处理样品，具有质谱电离源的仪器。它带有纸喷涂技术，该技术结合了纸基材和电离喷雾技术，可以进行单一的样品制备，并加速生物流体的质谱分析速度。
Velox 360可以和Thermo Fisher的Exactive Series质谱仪连联用。
Thermo Fisher Scientific today said that has listed its Prelude LX-4 MD HPLC as a Class I medical device with the US Food and Drug Administration for general clinical use.
The firm also said it inked a reseller agreement with Prosolia for that firm's automated sample handling and ionization source for mass spectrometry.
The Prelude LX-4 MD HPLC features four parallel channels to deliver up to four different separations to a mass spec in order to enhance sample throughput. Thermo said that the channels can run identical or different methods simultaneously.
Class I classification is for devices that pose the least risk to patients, and Class I devices are the least regulated under FDA's three classifications.
In a statement, Thermo Fisher President of Chromatography and Mass Spectrometry Dan Shine said that the company is committed to bringing LC-MS to the clinical market, "and this product is part of a larger initiative to make mass spectrometry more useful and accessible to the clinician."
Last June, Thermo Fisher registered its San Jose, Calif. facility with FDA as a medical device establishment ,allowing the firm to design and manufacture devices for analyzing samples from patients for in vitro diagnostic purposes.
Separately today, the company said it has reached a reseller deal with Prosolia to sell the Prosolia Velox 360 device with Thermo Fisher's mass spec instruments. The agreement provides a single point of contact for purchasing, installation, and service.
The Velox 360 is an automated sample handling and ionization source for mass spec. It features paper spray technology, which combines paper substrates with electrospray ionization for simple sample preparation and the acceleration of mass spec analysis of biological fluids.
Prelude LX-4 MD HPLC具有四个并行的通道，能够提供多达四种，不同的分离方式，这样可以提高到质谱的样品量。赛默飞表示，这些通道可以以相同的或者不同的方式运行。
居于一类的医疗器械，对于患者具有最小的风险，同时，FDA对三类医疗器械的监管中，对于一类是最少的。
在一份申明中，Thermo Fisher Chromatography and Mass Spectrometry总裁Dan Shine表示，该公司致力于LC-MS的临床市场，“这个产品仅仅是我们一个大计划的启动，我们计划让更多的临床医生接触和使用质谱。”
去年六月，Thermo Fisher在加利福尼亚圣何塞市注册。伴随着FDA批准的医疗器械的工厂的建立，该公司能够制造用于体外诊断的设备，这些设备能够分析患者的样本。
另外，今天该公司还表示，其与经销商Prosolia达成了协议，允许其销售Prosolia Velox 360和Thermo Fisher的质谱仪器。该协议包括了一个单一联系的采购，安装和相关服务。
Velox 360是一个可以自动处理样品，具有质谱电离源的仪器。它带有纸喷涂技术，该技术结合了纸基材和电离喷雾技术，可以进行单一的样品制备，并加速生物流体的质谱分析速度。
Velox 360可以和Thermo Fisher的Exactive Series质谱仪连联用。
Thermo Fisher Scientific today said that has listed its Prelude LX-4 MD HPLC as a Class I medical device with the US Food and Drug Administration for general clinical use.
The firm also said it inked a reseller agreement with Prosolia for that firm's automated sample handling and ionization source for mass spectrometry.
The Prelude LX-4 MD HPLC features four parallel channels to deliver up to four different separations to a mass spec in order to enhance sample throughput. Thermo said that the channels can run identical or different methods simultaneously.
Class I classification is for devices that pose the least risk to patients, and Class I devices are the least regulated under FDA's three classifications.
In a statement, Thermo Fisher President of Chromatography and Mass Spectrometry Dan Shine said that the company is committed to bringing LC-MS to the clinical market, "and this product is part of a larger initiative to make mass spectrometry more useful and accessible to the clinician."
Last June, Thermo Fisher registered its San Jose, Calif. facility with FDA as a medical device establishment ,allowing the firm to design and manufacture devices for analyzing samples from patients for in vitro diagnostic purposes.
Separately today, the company said it has reached a reseller deal with Prosolia to sell the Prosolia Velox 360 device with Thermo Fisher's mass spec instruments. The agreement provides a single point of contact for purchasing, installation, and service.
The Velox 360 is an automated sample handling and ionization source for mass spec. It features paper spray technology, which combines paper substrates with electrospray ionization for simple sample preparation and the acceleration of mass spec analysis of biological fluids.
The Velox 360 can be coupled with Thermo Fisher's Q Exactive Series mass spec instruments and the firm's triple quadrupole and ion trap instruments.（转化医学网360zhyx.com）
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